Clinical Research Associate (CRA) - Vaccine/Infectious Disease (Remote)

Role: Clinical Site Manager responsible for overseeing performance, compliance, and site development in a specified country. Objectives include ensuring study conduct aligns with ICH/GCP, local regulations, and company policies, while building strong site relationships across all trial phases. Responsibilities encompass managing site activities, conducting remote and on-site monitoring, regulatory document review, and supporting site selection and validation. The role involves collaboration with cross-functional teams, vendors, and regulatory authorities, with a focus on patient safety, data integrity, and quality standards. Requirements include an associate's degree with at least 5 years of healthcare experience and 2 years of direct site management in pharma/CRO, or a bachelor’s degree with 2+ years of monitoring experience. The position demands fluency in local languages and English, comprehensive knowledge of GCP, clinical trial processes, and IT skills. Key biopharma specifics involve clinical research, trial phases, compliance, and site performance management, with a travel expectation of 65-75%, primarily domestic and international. The role supports a hybrid work setup, emphasizing independence, cultural sensitivity, and problem-solving capabilities.